Conflict of interest

Hi. Can anyone help me with a question that I have been asked by a member of our clinical delivery team? If you are the PI/CI or on the delegation log can you participate in the study? Would this be classed as a conflict of interest or would this depend on the type of study i.e. observational v CTIMP?

I can't understand the question. If the person is the PI or anyone on the delegation log they will have trial related duties. Therefore there is conflict between the interests of the subject and the scientific performance of the trial related duties. If they want to take part then they should not be a member of the clinical trial team and therefore will avoid and conflict of interest. Probably best if you ask yourself what is scientific clinical research and what are clinical researchers? ICH E6 R2 is a good starting point. All scientific research seeks to minimise bias and increase accuracy and credibility of the results. This provides public assurance that the rights, safety, well-being and privacy of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki. If a member of the research team were to participate as a subject it would be impossible for the other researchers to treat that subject objectively and dispassionately, without bias and protecting their privacy and protecting their personal data. It would also be impossible for the researcher who is now a subject, to treat the other researchers and the other subjects objectively and dispassionately, without bias and protecting their privacy and protecting their personal data and the integrity and credibility of the data.